Clareon CNWET3 (UDI 00380652466424)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652466424), received between Feb 10, 2023 and Apr 8, 2026 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Material Deformation

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON HAD NOTICED SUB SURFACE NANO GLISTENINGS (SSNGS). IN THE SURGEON¿S OPINION, THE PRODUCT DID CAUSE OR CONTRIBUTE TO THE EVENT. THE PATIENT HAD NO HARM AND VISUALLY ASYMPTOMATIC. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815717 ↗
• MalfunctionFeb 25, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE HAPTICS FOUND TO BE SHEARED OFF. THE SURGEON EXPLANTED THE LENS ON THE SAME DAY AND DISPOSED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT HARM. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441664 ↗
• MalfunctionFeb 25, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE HAPTICS FOUND TO BE SHEARED OFF. THE SURGEON EXPLANTED THE LENS ON THE SAME DAY AND DISPOSED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT HARM. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441598 ↗
• MalfunctionFeb 25, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE HAPTICS FOUND TO BE SHEARED OFF. THE SURGEON EXPLANTED THE LENS ON THE SAME DAY AND DISPOSED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT HARM. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441544 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULD NOT READ OR SEE ANYTHING UP CLOSE. CLINICAL REASON IS MECHANICAL COMPLICATION OF IOL. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23066778 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION WAS NOT AS EXPECTED AFTER SURGERY. SHE HAS NOT SEEN IMPROVED VISION SINCE IMPLANTATION. IT TOOK 6 MONTHS BEFORE SHE COULD BE FIT FOR GLASSES WHICH HAVE NOT HELPED. SHE HAS BEEN TOLD SHE WILL NOT HAVE 20/20 VISION AGAIN IN THIS EYE. AFTER SURGERY SHE HAD SOME CORNEAL SWELLING. SHE EXPERIENCES PAIN AND PINCHING SENSATION IN THE EYE. SHE HAS A HISTORY OF DRY EYE SYNDROME. SHE USES UNSPECIFIED PRESERVATIVE FREE ARTIFICIAL TEAR (PFAT) AS NEEDED FOR THAT. SHE HAD A SECOND OPINION BY A SURGEON WHO SAID SHE WILL NOT HAVE 20/20 VISION AND DID NOT RECOMMEND REMOVING THE LENS. BUT THAT EVERYTHING LOOKED NORMAL. SHE COULD ONLY SEE UP CLOSE, BUT THAT WAS NOT GREAT EITHER. SHE FELT VERY UNHAPPY BECAUSE SHE SPENT A LOT OF MONEY ON COMPANY LENS AND THE SURGERY AND HAS NOT GOTTEN ANYTHING OUT OF IT. SHE IS A SECRETARY AND HAVING TROUBLE AT WORK. HER NEXT APPOINTMENT WAS SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Corneal Edema; Eye Pain

  MAUDE report 21901705 ↗
• MalfunctionNov 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, LENS BROKEN INTO TWO PIECES. SUBSEQUENTLY, IT WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH NEW INTRAOCULAR LENS. ADDITIONAL INFORMATION WAS RECEIVED THERE WAS NO PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 20638034 ↗
• MalfunctionJul 11, 2024Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED VIA REPLY CARD AS DEFECTIVE LENS NOTICED DURING SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED

  Patient problems: Insufficient Information

  MAUDE report 19720240 ↗
• InjuryJul 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE SHE HAS EXPERIENCE A BLIND SPOT IN BOTTOM PORTION OF LENS. BOTH EYES SEEM TO BE WORKING AGAINST EACH AND FLUORESCENT LIGHTS ARE EXTREMELY BRIGHT SINCE SURGERY.

  Patient problems: Loss of Vision; Visual Disturbances

  MAUDE report 19679864 ↗
• InjuryMay 30, 2024Use of Incorrect Control/Treatment Settings; Optical Decentration; Adverse Event Without Identified Device or Use Problem; Use of Incorrect Control/Treatment Settings; Optical Decentration; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND CLINICAL REASON FOR EXPLANT WAS MECHANICAL COMPLICATION OF IOL. THE IOL WAS EXCHANGED FOR UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) LENS MODEL 4 MONTHS 3 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19423850 ↗
• MalfunctionApr 5, 2024Scratched Material; Scratched Material

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048973 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT A 19.5 DIOPTER LENS WAS EXCHANGED FOR A 18.0 DIOPTER LENS DUE TO POOR VISION. THIS DOES NOT MEET CRITERIA FOR REPORTING BASED ON APPLICABLE MEDICAL DEVICE REGULATIONS. A LENS EXCHANGE FROM ONE POWER TO A DIFFERENT POWER IS AN ATTEMPT TO ADJUST OR FINE TUNE THE REFRACTIVE OUTCOME TRYING TO ACHIEVE A DESIRED TARGET WHEN THE INITIAL LENS CALCULATIONS DID NOT ACHIEVE THE INTENDED OUTCOME. THERE IS NO REPORTED DEFECT OR FAULT WITH THE LENS. AS PER SURGEON ORA GAVE AN IMPLANT RECOMMENDATION THAT RESULTED IN MYOPIA AND SUGGESTED AN AXIS FOR THE TORIC IOL THAT WAS 30 DEGREES OFF.

  Patient problems: Visual Impairment

  MAUDE report 17214272 ↗
• MalfunctionApr 10, 2023Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS IMPLANTED AND EXPLANTED DURING THE INITIAL PROCEDURE DUE TO SCRATCH ON LENS. THE SURGERY WAS COMPLETED WITH A NEW LENS.

  Patient problems: Insufficient Information

  MAUDE report 16707215 ↗
• InjuryFeb 10, 2023Material Opacification; Material Opacification

  A CONSUMER REPORTED THAT SINCE CATARACT SURGERY, SHE WAS UNHAPPY WITH VISUAL OUTCOME. IT WAS MENTIONED THAT SHE CANNOT SEE TELEVISION OR DRIVE, EYES HURT, RUN AND ITCH CONSTANTLY. SHE USE GLASSES FOR READING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LENS HAD HAZE AND UNABLE TO CLEARLY CORRECT WITH GLASSES OR CONTACT LENS. SHE MENTIONED THAT DRIVING WAS EXTREMELY LIMITED, ONLY WHEN ABSOLUTELY NECESSARY AND UNABLE TO READ A LICENSE PLATE FROM A CAR IN FRONT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Excessive Tear Production; Eye Pain; Irritability

  MAUDE report 16353770 ↗